Editing Botulinum toxin (section)

===Strabismus===
Ophthalmologists specializing in eye muscle disorders ([[strabismus]]) had developed the method of EMG-guided injection (using the [[electromyogram]], the electrical signal from an activated muscle, to guide injection) of local anesthetics as a diagnostic technique for evaluating an individual muscle's contribution to an eye movement.<ref>{{cite journal |vauthors = Magoon E, Cruciger M, Scott AB, Jampolsky A |title = Diagnostic injection of Xylocaine into extraocular muscles |journal = Ophthalmology |volume = 89 |issue = 5 |pages = 489–491 |date = May 1982 |pmid = 7099568 |doi = 10.1016/s0161-6420(82)34764-8 }}</ref> Because [[strabismus surgery]] frequently needed repeating, a search was undertaken for non-surgical, injection treatments using various anesthetics, alcohols, enzymes, enzyme blockers, and snake neurotoxins. Finally, inspired by [[Daniel B. Drachman]]'s work with chicks at Johns Hopkins,<ref>{{cite journal |vauthors = Drachman DB |title = Atrophy of Skeletal Muscle in Chick Embryos Treated with Botulinum Toxin |journal = Science |volume = 145 |issue = 3633 |pages = 719–721 |date = August 1964 |pmid = 14163805 |doi = 10.1126/science.145.3633.719 |s2cid = 43093912 |bibcode = 1964Sci...145..719D }}</ref> [[Alan B. Scott]] and colleagues injected botulinum toxin into monkey extraocular muscles.<ref name="Scott_1973">{{cite journal |vauthors = Scott AB, Rosenbaum A, Collins CC |title = Pharmacologic weakening of extraocular muscles |journal = Investigative Ophthalmology |volume = 12 |issue = 12 |pages = 924–927 |date = December 1973 |pmid = 4203467 }}</ref> The result was remarkable; a few picograms induced paralysis that was confined to the target muscle, long in duration, and without side effects.

After working out techniques for freeze-drying, buffering with [[albumin]], and assuring sterility, potency, and safety, Scott applied to the FDA for investigational drug use, and began manufacturing botulinum type A neurotoxin in his San Francisco lab. He injected the first strabismus patients in 1977, reported its clinical utility in 1980,<ref>{{cite journal |vauthors = Scott AB |title = Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery |journal = Ophthalmology |volume = 87 |issue = 10 |pages = 1044–1049 |date = October 1980 |pmid = 7243198 |doi = 10.1016/s0161-6420(80)35127-0 |s2cid = 27341687 }}</ref> and had soon trained hundreds of ophthalmologists in EMG-guided injection of the drug he named Oculinum ("eye aligner").

In 1986, Oculinum Inc, Scott's micromanufacturer and distributor of botulinum toxin, was unable to obtain product liability insurance, and could no longer supply the drug. As supplies became exhausted, people who had come to rely on periodic injections became desperate. For four months, as liability issues were resolved, American blepharospasm patients traveled to Canadian eye centers for their injections.<ref name="Boffey_1986" />

Based on data from thousands of people collected by 240 investigators, Oculinum Inc (which was soon acquired by Allergan) received FDA approval in 1989 to market Oculinum for clinical use in the United States to treat adult strabismus (crossed eyes) and [[blepharospasm]] (uncontrollable blinking).<ref>{{cite web | vauthors = Soucheray S, Beusekom MV, Beusekom MV, Schnirring L | title = FDA approves cosmetic use of botulinum toxin | date = 2002-04-18 | work =  Center for Infectious Disease Research & Policy (CIDRAP) | publisher = University of Minnesota | url = https://www.cidrap.umn.edu/botulism/fda-approves-cosmetic-use-botulinum-toxin | access-date = 2025-05-01 }}</ref> Allergan then began using the trademark Botox.<ref name="alg" /> This original approval was granted under the [[Orphan Drug Act of 1983|1983 US Orphan Drug Act]].<ref name="pmid20036435">{{cite journal | vauthors = Wellman-Labadie O, Zhou Y | title = The US Orphan Drug Act: rare disease research stimulator or commercial opportunity? | journal = Health Policy | location = Amsterdam, Netherlands | volume = 95 | issue = 2–3 | pages = 216–228 | date = May 2010 | pmid = 20036435 | doi = 10.1016/j.healthpol.2009.12.001 }}</ref>